With more than two million page views and more than 4,500 items, this blog provides news and commentary on public policy, business and economic issues related to the $3 billion California stem cell agency, officially known as the California Institute for Regenerative Medicine(CIRM). David Jensen, a retired California newsman, has published this blog since January 2005. His email address is djensen@californiastemcellreport.com.

Thursday, January 29, 2015

The California stem cell agency today put off adoption of new rules for the way it will hand out its last $1 billion, speeding the money to
researchers and attempting to improve the quality of research proposals.

The agency's staff deferred action on the proposal in order to spend more time refining it prior to action in March. The interim grant administration rules are designed to implement the CIRM 2.0 plan laid out by agency president Randy Mills, who has
been on the job since last May.

The rules will apply to the initial phase of CIRM 2.0, which
closes the first of its new, rolling application rounds tomorrow, and is subject to adjustment. CIRM (the California Institute for Regenerative
Medicine) expects to extend the new rules in one form or another to all
upcoming award rounds.

The agency calls the fast-track effort a radical change from
previous years. It is certain to have a major impact on many scientists.

The agency is funded by money that the state borrows (bonds). It has handed out roughly $2 billion and figures its remaining $1 billion will last until about 2020 when it will need additional financing.

The new regulations talk about such things as “real-time course
corrections,” background fraud checks, early and stringent budget review, restrictions
on appeals by rejected applicants and elimination of paper work.

Here are some excerpts from an agency memo identified as
coming from the “legal team.” It unfortunately does not contain a marked-up version showing language that has been deleted from the previous grant administration policy along with the new language.

Money

“Prior to CIRM 2.0, payments to grantees were made primarily
based on the calendar – disbursements keyed off the start date of the project
and were periodically made based on some given period of time following that
date. Under the proposed GAP(grant administration policy), however, for
clinical stage projects, CIRM will shift to a milestone-based payment schedule.
Thus, this section of the GAP describes the importance of the milestones and
how payments on the grant will only be made upon successful completion of the
milestones.

“Additionally, in many circumstances the grantee will be
allowed to keep unspent CIRM funds upon successful completion of the project,
to be spent on any other project of the grantee’s that is consistent with
advancing CIRM’s mission. This new process will incentivize grantees to advance
the project in the most efficient and shortest time possible, fulfilling CIRM’s
goal to accelerate such projects.”

Background checks

“The eligibility section has been drafted to reflect that
applicants will undergo a background check to ensure no prior or pending
records of fraud or misuse of funds.”

Budgets

“This new review will examine the proposed budget to
identify where proposed costs diverge from established market rates and where
opportunities for budget tightening may be found. To incentivize efficient
budgeting, where CIRM determines that a budget differs significantly from
market rates, conforming adjustments will have to be made before the application
will be brought forward for review by the GWG (the grant review group).”

Fast-track

“Rather than require submission of extensive documentation
regarding compliance with myriad protocols and processes – some CIRM-imposed
and others external – the proposed process will rely on certification of
compliance by the applicant, with the ability for CIRM to request supporting
documentation if cause to do so arises.”

Elimination of paper work

“Because most prior approval requests were routinely
granted, and therefore added little value to the process, prior approval
requests for rebudgeting and carryforward have been eliminated. We have also
eliminated prior approval requests for no-cost extensions because our new CIRM
awards will have project end dates that will be extended automatically as
needed to complete the final Operational Milestone. CIRM intends to increase
the latitude for grantees to pursue their research, while maintaining
visibility into and approval of any changes to key components of clinical
trials, manufacturing processes, or any other activities that meaningfully
impact milestones or suspension events.”

Clinical advisory panels (CAP) for each award

“CAPs will provide real-time course correction and will
focus more on acceleration opportunities than pure evaluation. CAPs will be
tailored for the needs of each project and will consist of CIRM and external
members, more nimbly sized than prior CDAP panels. CAPs will meet on a
quarterly basis (instead of annually with CDAP) and examine all relevant
information regarding project progression, possible roadblocks, and avenues for
progression.”

Appeals from rejected applicants

“Finally, in light of the rolling nature of the programs
which will allow unsuccessful applicants in many instances to reapply with
improvements to their applications, CIRM will limit the grounds for appeal of
Scientific Review to those based on demonstrable conflicts of interest (as
defined in the conflict of interest policy applicable to GWG members).”

About Me

The California Stem Cell Report is the only nongovernmental website devoted solely to the $3 billion California stem cell agency. The report is published by David Jensen, who worked for 22 years for The Sacramento Bee in a variety of editing positions, including executive business editor and special projects editor. He was the primary editor on the 1992 Pulitzer Prize-winning series, "The Monkey Wars" by Deborah Blum, which dealt with opposition to research on primates. Jensen served as a press aide in the 1974 campaign and first administration of Gov. Jerry Brown. (Time served: two years and one week.) He writes from his sailboat on the west coast of Mexico with occasional visits to land. Jensen began writing about the stem cell agency in 2005, noting that it is an unprecedented effort that uniquely combines big science, big business, big academia, big politics, religion, ethics and morality as well as life and death. The California Stem Cell Report has been identified as one of the best stem cell sites on the Internet. Its readership includes the media (both mainstream and science), a wide range of academic/research institutions globally, the NIH and California policy makers.